Naprelan

OVERDOSE

Significant naproxen overdosage may be characterized by drowsiness, heartburn,
indigestion, nausea or vomiting. Because naproxen sodium may be rapidly absorbed,
high and early blood levels should be anticipated. A few patients have experienced
seizures, but it is not clear whether or not these were drug-related. It is
not known what dose of the drug would be life threatening. The oral LD50 of
the drug is 500 mg/kg in rats, 1200 mg/kg in mice, 4000 mg/kg in hamsters and
greater than 1000 mg/kg in dogs. In animals 0.5 g/kg of activated charcoal was
effective in reducing plasma levels of naproxen. Patients should be managed
by symptomatic and supportive care following an NSAID overdose. There are no
specific antidotes. Hemodialysis does not decrease the plasma concentration
of naproxen because of the high degree of its protein binding. Emesis and/or
activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic
carthartic may be indicated in patients seen within 4 hours of ingestion with
symptoms or following a large overdose. Forced diuresis, alkalinization of urine
or hemoperfusion may not be useful due to high protein binding.

CONTRAINDICATIONS

NAPRELAN® (naproxen sodium) is contraindicated in patients with known hypersensitivity to
naproxen.

NAPRELAN® (naproxen sodium) should not be given to patients who have experienced asthma, urticaria,
or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely
fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients
(see WARNINGS- Anaphylactoid Reactions, and PRECAUTIONS-
Preexisting Asthma).